A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
Not Applicable
Completed
- Conditions
- Quality of Life
- Interventions
- Procedure: modified BII+Braun
- Registration Number
- NCT03624725
- Lead Sponsor
- Xue Yingwei
- Brief Summary
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
- Detailed Description
The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 592
Inclusion Criteria
- 18<age<75
- Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
- The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
- It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
- Preoperative ECOG performance status score 0/1
- Nutrition risk screening（NRS2002）
- Preoperative ASA score I-III
- Patient informed consent
Exclusion Criteria
- Pregnancy or breastfeeding women
- Severe mental illness
- History of upper abdominal surgery
- History of gastric surgery (including ESD/EMR for gastric cancer)
- 3 years of history of other malignant diseases；
- Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
- A history of unstable angina or myocardial infarction within 6 months
- History of cerebral infarction or cerebral hemorrhage within 6 months
- There is a history of sustained systemic corticosteroid treatment within 1 month
- Needs simultaneous surgical treatment of other diseases；
- Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
- Pulmonary function test FEV<1 predicted value 50%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description modified BII+Braun modified BII+Braun The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
- Primary Outcome Measures
Name Time Method Effects of quality of life The quality of life questionnaire was conducted at six months after surgery. The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gastrointestinal surgery of the affiated tumor hospital
🇨🇳Harbin, Helongjiang, China